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Draft Guidance May Miss Opportunity to Educate Americans About Importance of Lifestyle, Diet on High Blood Pressure

April 24, 2006

The Food and Drug Administration’s (FDA) advisory committee on cardiovascular and renal drugs will be chaired by and dominated by industry-connected scientists when it meets on Wednesday to evaluate draft labeling guidance for antihypertensive drugs. In a letter to FDA commissioner Dr. Andrew von Eschenbach, the Center for Science in the Public Interest (CSPI) says that meeting should be postponed to give the staff of the FDA’s Center for Drug Evaluation Research time to identify panelists who are free of conflicts of interest, and who could bring balance to the panel.

A balanced panel would at least have some members with expertise on how hypertension can be treated with diet and lifestyle changes, according to CSPI. The National Institute of Health’s Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure, or JNC-7, found that weight reduction, adoption of the low-sodium Dietary Approaches to Stop Hypertension (DASH) diet, physical activity, and moderation of alcohol consumption are “critical” for prevention of high blood pressure, and “indispensable” for managing it.

In testimony early this year, FDA commissioner Dr. von Eschenbach told a House committee that the FDA should not be prohibited from appointing advisory committee members with ties to drug companies because they may often be the best in the field. But CSPI points out that FDA did not include any of the non-conflicted scientists who served on JNC-7, or on another important government-funded trial, the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT).

“American hospitals and medical school faculties are filled with experts on preventing and treating high blood pressure, and it is simply not the case that all of them have financial relationships with drug makers,” said Merrill Goozner, director of the Integrity in Science Project at CSPI. “If the FDA can’t find any to serve on this particular panel, we stand ready to help them identify some.”

Wednesday’s panel will be chaired by University of Colorado professor William Hiatt, who has conducted blood pressure research on behalf of Bayer Pharmaceutical. The FDA posted conflict-of-interest waivers for eight others who will serve, but a final committee roster is unlikely to be publicly announced before the meeting.

CSPI also told the agency that its draft labeling guidance ignores the government’s own advice on the importance of lifestyle changes on lowering blood pressure, misrepresents the findings of the major government-funded science on hypertension, and would permit drug companies to make claims on drug labels that have not been reviewed by FDA. CSPI says that the labeling guidance would open the door for labeling abuse by letting drug companies tout the advantage of one drug over another without much evidence, and would squander and opportunity to educate Americans about the importance of diet and lifestyle in treating hypertension.

“The FDA acts as if it is much more concerned with pampering the pharmaceutical industry than it is preventing disease through better diets,” said CSPI executive director Michael F. Jacobson. “The best science on blood pressure shows that adoption of healthy lifestyles, including losing weight and reducing sodium, is indispensable to reducing blood pressure. Yet FDA does very little to help Americans make those changes.”

Some 65 million Americans have high blood pressure and more than half of them are on one of more than 60 drugs used to control the condition. The labeling guidance under consideration would let drug companies point to a drug’s additional effects on other conditions, such as congestive heart failure, angina, or kidney disease, as a reason for doctors to prescribe one drug over another. Drug companies conduct so-called seeding trials designed to do just that: to find some reason—any reason—for a physician to prescribe a newer, more expensive drug instead of an older, generic therapy.

An additional approach to labeling antihypertensive drugs says CSPI could be a notice on the label and inserts would encourage patients to talk to their doctors about lifestyle changes, and state that “weight loss, diets rich in vegetables and fruits, and diets low in salt are simple ways of treating high blood pressure. Lowering your blood pressure through such changes could save you the cost and side effects of this (and possibly other) medications.” Labeling for some diabetes drugs and cholesterol-lowering statin drugs could bear similar messages, says CSPI.